Medicine
Adquey 1% ointment
Adquey 1% ointment is a prescription medicine containing Difamilast for topical use, marketed by Acrotech Biopharma, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C–25°C (68°F–77°F), excursions permitted to 15°C–30°C (59°F–86°F)…
Key facts
- Active ingredient (INN)
- Difamilast
- Brand
- Adquey
- Strength
- 1%
- Dosage form
- Ointment
- Route
- Topical
- Packs
- 1 tube
- Marketing authorisation holder
- Acrotech Biopharma
- Manufacturer
- Acrotech Biopharma
- Origin register
- US FDA, United States
- Storage
- Store at 20°C–25°C (68°F–77°F), excursions permitted to 15°C–30°C (59°F–86°F). Store away from direct sunlight, heat, and moisture.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 25 February 2026
- Identifiers
- RxCUI 2738419, 2738424DailyMed set ID 46c95e41-fa29-4e11-9d94-0fd4f0291c34NDC 72893-017Application NDA219474
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube in 1 carton / 3 g in 1 tube | 72893-017-07 | Acrotech Biopharma | 25 February 2026 |
| 1 tube in 1 carton / 27 g in 1 tube | 72893-017-08 | Acrotech Biopharma | 25 February 2026 |
| 1 tube in 1 carton / 85 g in 1 tube | 72893-017-09 | Acrotech Biopharma | 25 February 2026 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 12 February 2026 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Difamilast is a phosphodiesterase 4 inhibitor indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. It is available as ointment for topical use. MedsAcross supplies Difamilast for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about DifamilastFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- ADQUEY prescribing information (Acrotech Biopharma) · U.S. National Library of Medicine, DailyMed
Need Adquey 1% ointment for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.